If you’re a fresher or early-career professional looking to enter the rapidly growing medical device industry, this opportunity could be the ideal first step. A new opening has been announced for the role of Quality Assurance & Regulatory Affairs (QARA) Associate in Pune. This position is perfect for candidates who are detail-oriented, compliance-focused, and interested in quality systems and regulatory processes.
Let’s explore everything you need to know about this promising role 👇
📍 Job Overview
Position: QARA Associate
Location: Pune
Experience: 0–1 Year
Industry: Medical Devices 🏥
Application Email: hr@smartqr.co.in
This role offers hands-on exposure to regulatory frameworks, documentation systems, and quality standards used in the medical device sector.
💼 Key Responsibilities
As a QARA Associate, your responsibilities will focus on ensuring compliance and supporting quality operations.
📋 Quality Management System (QMS)
Assist in implementing and maintaining a strong Quality Management System aligned with ISO 13485:2016 standards to ensure products consistently meet customer and regulatory requirements.
📂 Documentation & Record Control
Maintain accurate records, controlled documents, filing systems, and documentation trails for audits and inspections 📑
🏛 Regulatory Submissions
Support regulatory filings and submissions to CDSCO (Central Drugs Standard Control Organization) for medical device approvals in India.
⚠️ Risk Management
Work on risk analysis and mitigation activities based on ISO 14971 standards to ensure product safety and reliability.
🧪 Design & Development Support
Help prepare Design History Files (DHF) and support Verification & Validation (V&V) documentation during product development.
🔍 Audits & CAPA
Assist during internal/external audits and help implement Corrective and Preventive Actions (CAPA) for quality issues.
💻 Software Compliance
Support compliance aligned with IEC 62304, especially if products involve medical device software.
🎯 Skills Required
Successful candidates should possess:
- 🔎 Strong attention to detail
- 📊 Analytical and problem-solving ability
- 🗂 Good organizational skills
- 💬 Effective communication skills
- 📑 Interest in documentation and compliance systems
🎓 Eligibility Criteria
Ideal applicants may have qualifications in:
- B.Pharm
- M.Pharm
- Biomedical Engineering
- Life Sciences
- Related healthcare/science fields 🎓
Preferred but not mandatory:
- Basic knowledge of medical device regulations
- Understanding of ISO standards
- Internship/project experience in QA/RA
Freshers with a learning mindset are strongly encouraged to apply 🙌
🌱 Why Build a Career in QARA?
Quality Assurance & Regulatory Affairs is one of the most stable and rewarding domains in healthcare.
📈 Growing Demand
As regulations increase, skilled QA/RA professionals are needed more than ever.
🌍 Global Opportunities
Work with international standards and compliance systems.
🔐 Strong Job Security
Compliance functions are essential in every medical device company.
🚀 Long-Term Growth
Advance into senior QA roles, auditing, regulatory strategy, or global compliance leadership.
📩 How to Apply
Interested candidates can send their updated resume directly to:
Make sure your CV highlights:
- Relevant education
- Internships/projects
- QMS exposure
- Documentation experience
- Knowledge of ISO/CDSCO standards
💡 Resume Tips for Freshers
- Use keywords like ISO 13485, CAPA, QMS, CDSCO, Regulatory Affairs
- Mention any audit/documentation work
- Showcase accuracy and attention to detail
- Add certifications related to QA/RA if available
🔑 Final Thoughts
Breaking into the medical device industry can be challenging, but a QARA Associate role gives you an excellent foundation. If you’re serious about building a long-term career in quality, compliance, and healthcare innovation, this opening in Pune is worth applying for.
Don’t miss the chance to start your professional journey in a meaningful and high-growth field 🌟
